The Government Accountability Office (GAO) has agreed to investigate power morcellators, a type of surgical tool that until recently was widely used to perform minimally-invasive hysterectomies and myomectomies (fibroid removals). As reported earlier this month by The Wall Street Journal, the devices were on the market for two decades before the U.S. Food & Drug Administration (FDA) warned the public of their potential to spread and upstage undetected uterine cancer cells during gynecological surgeries.
The GAO’s decision to investigate the power morcellator controversy comes after a dozen member of Congress wrote the agency seeking the probe.
“Despite the long history of this device, only recently has the FDA put out guidance that the use of laparoscopic power morcellators increases the risk of spreading unsuspected cancers in women to as high as 1 in 352 cases,” the lawmakers said in the August 7th letter. “As of the date of this letter, the morcellator remains on the market.”
Signatories to the letter included: Reps. Mike Fitzpatrick (R-Pa.), Louise Slaughter (D-N.Y.), Ralph Abraham (R-La.), Rosa DeLauro (D-Conn.), Bill Pascrell, Jr. (D-N.J.), Lou Barletta (R-Pa.), Doug LaMalfa (R-Calif.), Anna G. Eshoo (D-Calif.), Jan Schakowsky (D-Ill.), Chris Smith (R-N.J.), Stephen Lynch (D-Mass.), and Rick Larsen (D-Wash.).
The letter asks that the GAO investigate whether the FDA’s 510(k) clearance process sufficiently identified the morcellator cancer risk before the devices were approved for sale, and whether adverse event reporting regulations were appropriately followed by manufacturers, importers, user facilities, and the FDA. The lawmakers also want information on the type of training provided to practitioners who perform morcellator hysterectomy and myomectomy, and they want to know what steps the FDA is taking to determine whether or not morcellators should remain on the market.
A growing number of power morcellator lawsuits have been filed in U.S. courts since the controversy began making headlines in late 2013. On October 1, 2015, the U.S. Judicial Panel on Multidistrict Litigation (JPML) will hear oral arguments on a proposal to consolidate all federal morcellator claims in a single U.S. District Court for the purposes of coordinated pretrial proceedings.
There is still time for the alleged victims of morcellator cancer to join this growing litigation. To discuss your case with an attorney at Bernstein Liebhard LLP, please call to arrange for a free, no-obligation case review today.